Ready-to-use co-solvents pharmaceutical composition in modified flexible plastic container
AssigneesHq Specialty Pharma Corporation, Welgrace Research Group
InventorsGeorge OWOO, Erica Castagna
Life of this patent
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Abstract
A ready-to-use injectable, co-solvents (ternary mixture) pharmaceutical composition for the treatment of cardiac conditions and diagnosis applications, comprising methyl-3-[4-(2-hydroxy-3-isopropylamino) propoxy]phenylpropionate hydrochloride (Esmolol hydrochloride), a buffering agent, ethanol and propylene glycol which capable of been stored in modified flexible plastic container, heat-sterilized without deformation and/or integrity of the closure system been compromised, as well as method for its manufacture, is disclosed.
Claims18
A co-solvent sterile premixed pharmaceutical product stored in a non-PVC flexible plastic container, wherein said pharmaceutical product has a solution pH between 4.5 and 5.5 and comprises:
- a. 5 to 40 mg/mL methyl-3-[4-(2-hydroxy-3-isopropylamino) propoxy]phenylpropionate hydrochloride (esmolol hydrochloride),
- b. a buffering agent to maintain a solution pH between 4.5 and 5.5,
- c. 0.1% to 3 w/v % of ethyl alcohol, and
- d. 0.1% to 3 w/v % of one of propylene glycol or glycerin;
- and
- wherein said pharmaceutical product is contained in a sealed container and heat-moist sterilized for a period of time sufficient to render the composition sterile.
Dependencies are inferred from the claim text.